January 10, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Daiichi Sankyo Bets $250 Million+ on Kite Pharma’s CAR-T Drug
Kite Pharma , headquartered in Santa Monica, Calif., announced today that it has signed a strategic partnership deal with Japan’s Daiichi Sankyo Co for axicabtagene ciloleucel in Japan.
Kite’s lead product candidate, axicabtagene ciloleucel, involves engineering a patient’s T cells to express a chimeric antigen receptor (CAR) to target antigen CD19. CD19 is expressed on the surface of B-cell lymphomas and leukemias. This redirects the immune T-cells to kill the cancer cells.
Under the terms of the deal, Daiichi Sankyo will take over development and commercialization of the compound in Japan. Kite will receive $50 million upfront and be eligible for future payments up to $200 million for development and commercial milestones. Kite may also receive low to mid-double digit royalties.
Kite will provide specific technical transfer services for Daiichi Sankyo. Daiichi Sankyo has a specific period in which to license additional Kite candidates for Japan, including KITE-718, Kite’s T-cell receptor candidate targeting MAGE-A3/A6 and other products that may be eligible for U.S. investigational new drug application filings over the next three years. Upfront and milestone payments are possible for up to $200 million per product candidate, as well as low to mid-double digit royalties. Kite will hold all development and commercialization rights outside of Japan.
“We are thrilled to partner with Daiichi Sankyo, a market leader in Japan who shares our vision for engineered T-cell therapy and has strong development capabilities in oncology,” said Arie Belldegrun, Kite’s chairman, president and chief executive officer, in a statement. “We have a strategic roadmap to commercialize axacabtagene ciloleucel globally while focusing Kite’s development and commercialization efforts in the United States and Europe. Daiichi Sankyo’s commitment to bring autologous T-cell therapy to patients in Japan will complement our strategy and demonstrates the significant value in our pipeline, as well as the commercial potential for autologous T-cell therapy globally.”
On a Roll, Kite Pharma Establishes Joint Venture in China With Fosun Pharma
Kite also revealed a joint venture (JV) in China with Fosun Pharma. Fosun is paying Kite $40 million upfront. $20 million is for the start of clinical activities and manufacturing, along with a group of milestones payments in a 50/50 split.
Helen Kim, Kite’s chief of business development told Endpoints News, “They’re very strong in oncology. They just have a huge presence” in China.
Of the Daiichi Sankyo deal, Kim said, “Daiichi Sankyo made a strategic decision to get into cell therapy. The structure is a more traditional licensing agreement. We will provide technology transfer on the manufacturing. It’s their desire to do the manufacturing” in Japan.
CAR-T therapy has become a bit of a two-horse race between Kite and Novartis . At one point Juno Therapeutics was involved, but has had problems with five patient deaths related to brain toxicity in its lead program.
“We are very enthusiastic about this partnership with Kite which has the most advanced technology platform in this area and the potential for cell-based therapy to change the way in which we treat cancer in Japan,” said Koichi Akahane, Daiichi Sankyo’s Japan Head of Oncology R&D, in a statement. “We believe we can leverage the pioneering research conducted by Kite to potentially accelerate development and commercial availability of axicabtagene ciloleucel in Japan for those patients suffering from B-cell malignancies.”
